Life Science Regulatory Update: AI IP, Biosimilar Approvals, Cell Therapy
Summary
FDA published new guidance in February-March 2026 allowing biosimilar applicants to use foreign clinical trial data to accelerate U.S. approval for rare and ultra-rare diseases. The agency also indicated increased flexibility for iterative manufacturing changes in cell and gene therapies, creating new IP strategy considerations. Knobbe Martens summarizes these regulatory developments for life science companies and their counsel.
What changed
FDA guidance released February 23, 2026 and March 9, 2026 permits biosimilar applicants to utilize clinical data from outside the United States to support U.S. approval pathways, with particular focus on rare and ultra-rare disease treatments. Additionally, the FDA signaled greater acceptance of iterative manufacturing changes for cell and gene therapies, which may allow sponsors to capture patent protection on process innovations that emerge after initial approval.
Biosimilar sponsors should evaluate foreign datasets to potentially reduce U.S. development costs and timelines. Cell and gene therapy developers should consider patent strategies that account for post-approval manufacturing innovations with independent commercial value. IP practitioners conducting diligence should recognize that regulatory flexibility may support multiple manufacturing pathways for a single approved product, each with distinct patent considerations.
Source document (simplified)
April 6, 2026
Life Science Update | March 2026
Bailey Arenberg, Kenneth Aruda, Ph.D., Michael Fuller, Robert Hilton, Ph.D, Phillip Minnick, Ph.D., Makoto Tsunozaki Ph.D. Knobbe Martens + Follow Contact LinkedIn Facebook X Send Embed
AI and Genomics: A New Era of Personalized Medicine
Robert J. Hilton, Ph.D. & Bailey R. Arenberg
Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions.
IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Makoto Tsunozaki, Ph.D. & Kenneth O. Aruda, Ph.D.
Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent strategies that account for innovations that emerge later and carry independent value from an earlier process.
Greater regulatory acceptance of iterative manufacturing changes by the FDA may increase the value of innovation beyond final commercial configurations.
In IP diligence and landscape analyses, practitioners should be mindful that regulatory flexibility may permit multiple manufacturing pathways to support a single approved product, each with potentially distinct IP considerations.
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Michael L. Fuller & Phillip J. Minnick, Ph.D.
New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare and ultra-rare diseases.
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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